PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE
Recruiting · NCT05022914 · Observational (researchers observe without assigning treatment) · Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
View the official record on ClinicalTrials.gov →What this trial is about
This observational study was designed to evaluate progression free survival after PSMA-PET/CT based salvage approach for patients affected by biochemical relapse after radical prostatectomy.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Signed informed consent
- Age \>18
- Patient suitable for 68Ga-PSMA PET/CT re-staging according to clinical practice (Previous radical prostatectomy with histological result of Prostate adenocarcinoma +/- postoperative prostate bed radiotherapy (adjuvant or salvage setting), with a biochemical relapse defined as a PSA \> 0.2 and \<1
Exclusion criteria
- ADT administration within 6 months from study enrollment
- Persistent elevation of PSA after RP measured within 16 weeks from surgery (\> 0.1 ng/ml)
Where it is running
1 location listed.
- AOU Careggi Radiation Oncology Unit - Florence, Italy